Hepatitis is inflammation of the liver, which may be caused by a family of viral infections that affect the liver, the most common types being Hepatitis A, Hepatitis B, and Hepatitis C. Hepatitis A, Hepatitis B, and Hepatitis C are diseases caused by three different viruses. Whereas Hepatitis A appears only acutely, acute infections of Hepatitis B and Hepatitis C may become chronic. Moreover, while there are vaccines to prevent Hepatitis A and Hepatitis B, there is currently no vaccine to prevent Hepatitis C infection.
Hepatitis C is an infectious disease that primarily affects the liver and is caused by the HCV. HCV is spread primarily through contact with the blood of an infected person. In the initial stages of infection, infected individuals exhibit mild or no symptoms. HCV persists in the liver in about 75-85% of those initially infected. Over the long term, Hepatitis C can lead to liver disease and occasionally cirrhosis, which can lead to liver failure, liver cancer, or esophageal and gastric varices. Additionally, the majority of liver transplants are due to Hepatitis C infections.
HCV is a small enveloped positive-sense single-stranded RNA virus of the family Flaviviridae and genus Hepacivirus. HCV is the cause of hepatitis C as well as some cancers, such as Liver Cancer (hepatocellular carcinoma (HCC)) and lymphomas. Based on genetic differences between HCV isolates, the HCV species is classified into seven genotypes, 1, 2, 3, 4, 5, 6, and 7.
In the field of molecular diagnostics, the amplification and detection of nucleic acids is of considerable significance. Such methods can be employed to detect any number of microorganisms, such as viruses and bacteria. The most prominent and widely-used amplification technique is the Polymerase Chain Reaction (PCR). Other amplification techniques include Ligase Chain Reaction, Polymerase Ligase Chain Reaction, Gap-LCR, Repair Chain Reaction, 3 SR, NASBA, Strand Displacement Amplification (SDA), Transcription Mediated Amplification (TMA), and Qβ-amplification.
Automated systems for PCR-based analysis often make use of a real-time detection of product amplification during the PCR process in the same reaction vessel. Key to such methods is the use of modified oligonucleotides carrying reporter groups or labels.
An estimated 3.2 million people in the U.S. have Hepatitis C, but many of them do not know, because the symptoms of an initial infection are so mild or non-existent. Roughly 10% of all HCV infections in the U.S. result from genotype 3 (i.e., HCV Genotype 3) infection. As compared to other HCV genotypes, individuals infected with HCV Genotype 3 exhibit relatively faster rates of fibrosis progression, higher prevalence of severe steatosis, and a higher incidence of hepatocellular carcinoma. Therefore, there is a need in the art for a quick, reliable, specific, and sensitive diagnostic method for detecting and quantifying HCV, such as HCV Genotype 3.